Cleared Traditional

SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

K943268 · Streck Laboratories, Inc. · Hematology
Dec 1994
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K943268 is an FDA 510(k) clearance for the SCS-1000 (SYSMEX CALIBRATOR SYSTEM), a Calibrator For Red-cell And White-cell Counting (Class II — Special Controls, product code KSA), submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on December 15, 1994, 161 days after receiving the submission on July 7, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8185.

Submission Details

510(k) Number K943268 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1994
Decision Date December 15, 1994
Days to Decision 161 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KSA — Calibrator For Red-cell And White-cell Counting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8185

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